Diabetes mellitus, Type 2 MedDRA version: 15.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: Insulin degludec liraglutide PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin degludec
CAS Number: 844439-96-9
Concentration unit: U/ml unit(s)/millilitre
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects with Type 2 Diabetes Mellitus - Male or female = 18 years of age - HbA1c 7.0-9.0% (53-75 mmol/mol)(both inclusive) - Subjects on stable daily dose of sulphonylurea (= half of the max approved dose according to local label) with or without metformin (= 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1) - Body Mass Index (BMI) = 40 kg/m^2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 321 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 108
Exclusion criteria
Exclusion criteria: - Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combination with metformin) = 90 days prior to screening visit (Visit 1) - Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids) - Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide) - Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator) - Screening calcitonin = 50 ng/l - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) - Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures - Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator’s opinion - Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the Type 2 Diabetes Mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product - History of chronic pancreatitis or idiopathic acute pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm superiority of insulin degludec/liraglutide compared to insulin degludec/liraglutide placebo in controlling glycaemia as add-on treatment in insulin naïve subjects with Type 2 Diabetes Mellitus (T2DM) inadequately controlled on sulphonylurea (SU) with or without metformin therapy after 26 weeks of treatment.;Secondary Objective: To compare general efficacy and safety of the addition of insulin degludec/liraglutide and insulin degludec/liraglutide placebo in insulin naïve subjects with T2DM inadequately controlled on SU with or without metformin therapy compared to after 26 weeks of treatment.;Primary end point(s): Change in glycosylated haemoglobin (HbA1c) from baseline (randomisation, Visit 2) ;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Responders achieving pre-defined target for HbA1c o HbA1c < 7.0% (53 mmol/mol) o HbA1c = 6.5% (48 mmol/mol) 2 - Change from baseline in fasting plasma glucose (FPG) 3 - Change from baseline in body weight 4 - Number of treatment emergent (confirmed) hypoglycaemic episodes 5 - Number of treatment emergent adverse events (AEs) ;Timepoint(s) of evaluation of this end point: 1 - After 26 weeks of treatment 2 - After 26 weeks of treatment 3 - After 26 weeks of treatment 4 - During 26 weeks of treatment 5 - During 26 weeks of treatment | — |
Countries
Bulgaria, Canada, Germany, India, Israel, Turkey, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed